Stryker Corp.'s Trevo clot-retrieval devices won de novo authorization from US FDA Sept. 2, the first time FDA has OK'd a device as a first-line treatment for ischemic stroke. The devices were developed by Concentric Medical Inc., which was acquired by Stryker for $135m in 2011. (Also see "Stryker Buys Concentric Medical To Enter Acute Ischemic Stroke Market" - Medtech Insight, 5 September, 2011.)
FDA’s move will allow the clot-retrieval devices, known as the Trevo ProVue and XP ProVue retrievers, to be used as a treatment for ischemic strokes when used alongside a clot-dissolving...